Detection of Silent Atrial Fibrillation aFter Ischemic StrOke (NCT02684825) | Clinical Trial Compass
CompletedNot Applicable
Detection of Silent Atrial Fibrillation aFter Ischemic StrOke
Italy317 participantsStarted 2015-10
Plain-language summary
The primary objective of this study is to evaluate whether, in patients with first-ever atherothrombotic or lacunar stroke without any previous history of atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT), the detection of AF/AFL/AT (silent or symptomatic) by using a continuous cardiac rhythm monitoring with implantable loop recorder (ILR) during the first 12 months of observation is higher than the detection by using a standard cardiac monitoring (physical exam, 12-lead electrocardiogram \[ECG\] at baseline, 3, 6, and 12 months and Holter ECG at 3 months) in the same period of time.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥65 years old in the presence of at least one of the following vascular risk factors: hypertension; diabetes; vascular disease (previous myocardial infarction, peripheral arteriopathy).
* Age between 60 and 64 years old in the presence of at least two of the following vascular risk factors: hypertension; diabetes; vascular disease (previous myocardial infarction, peripheral arteriopathy); smoking.
* Recent (30-60 days after symptom onset) diagnosis of first-ever ischemic stroke. Ischemic stroke is defined as an event characterized by the sudden onset of acute focal neurological symptoms, MR or CT findings consistent with ischemic stroke, and no evidence of other neurological disorders clinically or radiographically to explain. Patients with reversible neurological deficit within 24 hours (clinical TIA), but with a cerebral injury of ischemic origin visible on neuroimages and corresponding to patient symptoms, have to be classified as having an ischemic stroke and considered for the study.
* Diagnosis of atherothrombotic and lacunar etiology, defined according to the TOAST classification criteria and standard diagnostic protocols that have to be fulfilled before randomization (medical history; risk factors; symptoms; cerebral MR and/or CT; 12-lead ECG and/or Holter ECG and/or other standard heart rhythm monitoring procedure; transthoracic and/or transoesophageal echocardiogram; intra- and extracranial vessel ultrasonography and/or CT-Angiography and/…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.